Last week, I met with a woman who was planning pregnancy. She had a long history of generalized anxiety disorder and panic disorder and had done very well over the past 10 years on [...]
In 2015, the U.S. Food and Drug Administration (FDA) proposed major revisions to prescription drug labeling -- the Pregnancy and Lactation Labeling Rule or PLLR -- in order to provide more accurate and helpful information [...]
In 2015, we first reported on SAGE-547 (SAGE Therapeutics), a new medication for the treatment of postpartum depression (PPD). SAGE-547, now called brexanolone, is an allosteric modulator of GABAA receptors. Since that time, Sage Therapeutics [...]
The US Food and Drug Administration (FDA) has approved another medication for the management of pregnancy-related nausea and vomiting. It is not really a new medication but is similar to Diclegis, a combination doxylamine succinate [...]
The U.S. Food and Drug Administration (FDA) has proposed major revisions to prescription drug labeling in order to provide more accurate and helpful information on the effects of medications used during pregnancy and breastfeeding. The [...]
In 2006, Chambers and colleagues published an article linking selective serotonin reuptake inhibitor (SSRI) antidepressant use during late pregnancy to an increased risk of persistent pulmonary hypertension in the newborn (PPHN). PPHN is a cardiovascular [...]
The following post was first published in OB/GYN News.
Last week, the U.S. Food and Drug Administration (FDA) published a report outlining the new standards for how to present information regarding the safety of medications used during pregnancy and breastfeeding: “The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.” These changes will be put into effect by June 2015.
This is a very nice article published by the College of Psychiatric and Neurologic Pharmacists discussing the limitations of the current FDA pregnancy category labeling system.
There have been multiple recent reports indicating that the use of valproate during pregnancy may be associated with lower IQ, cognitive problems, and developmental delays in exposed children. This has prompted the FDA to issue a warning regarding the use of valproate-containing drugs, including Depakote and Depakene, during pregnancy: